Pharmacovigilance

Integrated mechanisms and processes for monitoring the safety of medicines are essential to a well-functioning pharmaceutical sector. A positive benefit-to-risk balance should precede access to market; however, most regulatory decisions take place early in the product lifecycle, and are based on limited data from clinical trials that may be of relatively short duration with limited numbers and types of subjects.

It is critical, therefore, that medicines continue to be monitored for safety and effectiveness once they enter the market under real-life conditions. For some medicines, issues will only emerge under real-world conditions,  as a result of prolonged use, following use in specific subpopulations, in patients with multiple co-morbidities, or in combination with other medicines. In some cases, rare adverse effects only emerge after a product is used over many years or by large numbers of patients, or both. The activities related to the detection, assessment, understanding, and prevention of these adverse effects are known collectively as pharmacovigilance.[1]

As part of its efforts to increase access to essential medicines, SIAPS works to establish and strengthen pharmacovigilance (PV) systems in low- and middle-income countries, where mechanisms to ensure medicines safety can often be inadequate or under-resourced. Recognizing that even relatively rare problems associated with medicines use can have a major impact on patient safety, prescriber behavior, patient adherence, and overall health outcomes, SIAPS uses a systems-based approach to support countries in understanding and establishing both passive and, where appropriate, active approaches to the identification of medicine-related problems.

Importantly, medicine-related problems are not limited to adverse drug reactions, but also include the adverse effects of medication errors and product quality issues. Viewing PV through a systems-strengthening lens also allows SIAPS to ensure these activities are harmonized with other components of the pharmaceutical system, including regulatory approval processes; medicines selection, procurement, and distribution; and clinical treatment guidelines. To that end, SIAPS looks for opportunities to engage in effective PV practices at multiple entry points—at pre-market evaluation, at the facility level, in clinics, and even in patients’ homes—and to ensure that even the most decentralized mechanisms can usefully be aggregated and feed a larger, comprehensive PV framework.

Using the SIAPS Integrated Pharmacovigilance Assessment Tool (IPAT), SIAPS helps countries assess their existing pharmacovigilance processes, structures, and capacity to identify strengths, weaknesses, and gaps. SIAPS then uses these assessments to recommend options and help implement selected interventions to strengthen pharmacovigilance systems. To date, SIAPS has worked to strengthen pharmacovigilance systems in more than 10 low- and middle-income countries. Selected interventions and results include:

  • Supporting the implementation of a decentralized PV system in South Africa that has successfully collected data on adverse events since 2010;
  • Initiating sentinel site-based surveillance systems in Swaziland and Namibia enabling the collection of comprehensive adverse event data on antiretroviral and anti-TB medicines;
  • Developing and implementing a PV strategy for the national tuberculosis program in Ukraine to improve reporting and capture of adverse event data, expand active surveillance, and conduct quality checks.

By strengthening PV systems in parallel with our efforts to make medicines more widely available, SIAPS is working to ensure medicines safety, refine medicines selection, and support the collection of data to inform decision making at all levels of the health system. In this way, improved availability of medicines can be supported by more robust health systems and ensure delivery of better health outcomes.

[1] Definition adapted from the World Health Organization: http://www.who.int/medicines/areas/quality_safety /safety_efficacy/pharmvigi/en/